Commentary: Developing affordable, accurate test kits for COVID-19 one of the biggest challenge this outbreak
EAST LANSING, Michigan: As COVID-19 spreads from China, public health officials the world over mobilise, preparing for declaration of a global pandemic.
“It’s not so much a question of if this will happen anymore, but rather more a question of when this will happen,” said Anne Schuchat, principal deputy director of the US Centers for Disease Control.
Preparation includes a scramble to understand transmission patterns by developing and distributing accurate tests. Expanded testing may spike case totals, but early detection, isolation and treatment reduces the spread of the disease and fatalities.
The World Health Organization declared a global health emergency on Jan 30, urging a coordinated global response after reports of new coronavirus cases began in Wuhan and spread beyond China.
Over a month later, more than 100 countries report confirmed cases – 80,000 in China, 9,000 in Italy, and 7,000 in South Korea and Iran, and more.
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TESTING HAS EVOLVED
The world relies on China’s large pool of cases for research on treatment and testing.
As diagnostic testing evolved, China has revised its methods for tallying confirmed cases. Not all clinics had access to tests, and for a week in February, totals relied on clinical diagnosis.
Chinese researchers have also conducted a study of more than 1,000 patients, reporting that computed tomography scans outperform lab testing for COVID-19 diagnosis. The researchers thus recommended CT scans to be used as a primary tool for current COVID-19 detection in epidemic areas.
But Chest CT scans cost about US$1,000 in the US and US$140 in the Netherlands. Blood, nasal, mouth-swab and other rapid tests cost less.
Public health officials have shared findings on COVID-19 and governments decide on a range of strategies while approving diagnostic testing products and organising delivery to local health departments.
China quickly identified and released the genetic sequence for the coronavirus in mid-January. Soon afterward, China’s national institute of infectious diseases and a company in Jiangsu Province announced the joint development of a technology that can promptly determine whether the virus is present, reports the Nikkei Asian Review.
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THE CHALLENGE WITH DEVELOPING TEST KITS
Developing and distributing new test kits is a challenge. In-vitro diagnostic testing makes up a sliver of overall health care spending, for example, representing less than 1 per cent in Europe for 2017.
Developers must consider health care systems, logistics, regulations, supply chains, costs and political commitment. The tests must be tested themselves with live virus samples to assess sensitivity and accuracy.
Diagnostic tests, categorised as medical devices, are “usually conducted in laboratories, private or public, equipped with appropriate and sometimes expensive instrumentation and staffed with trained and qualified personnel to perform the tests,” reports the National Center for Biotechnology Information.
The goal is for point-of-care testing near patients for fast delivery of results to guide treatment decisions.
MAKING SOME HEADWAY
By mid-February, WHO appointed 16 referral laboratories for confirming new cases in China, Japan, Singapore, Australia, Thailand, India, the United States, South Africa, Senegal, Russia, Germany, the Netherlands, the United Kingdom and France.
Another 150 laboratories have technology for identifying the virus. Agencies in China, Germany, Hong Kong, Japan, Thailand and the United States have shared protocols for molecular assays online. The WHO is in regular contact with researchers and manufacturers.
However, Japan has warned that distribution of fully tested kits could take at least three months. A test distributed to US labs in early February was reported as flawed, and local health departments are waiting for new kits. Simple tests tend to have less accuracy, warned developers.
For now, the public health goal is to use limited tests for patients showing symptoms. In Japan, guidelines say people should get tested if they have cold-like symptoms, a fever of 37.5 Celsius or extreme tiredness or breathing problems for four days or more.
Japan’s health minister reported an average of 900 tests per day even as hospitals turn people away. Efforts have focused on people who have travelled to China or show symptoms. People with symptoms should contact health providers and otherwise stay at home.
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WHO has offered advice for selecting diagnostic tests, recommending certification and approval from European and US regulators and manufactured in facilities that meet conditions from the International Organization for Standardization.
In the United States about 40 labs besides the Communicable Disease Center (CDC) have capability to test for the virus, with more coming on next week. Currently, hundreds of samples are tested with overnight results, explained Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases.
Six additional labs in the United States plan to start testing this week.
Singapore has identified links among cases by tracking patient movements and contacts and using a serological test from Duke-NUS Medical School.
“The research team at Duke-NUS Medical School had earlier successfully cultured the COVID-19 virus in less than a week after Singapore confirmed its first COVID-19 case,” reports the Ministry of Health in Singapore. Researchers then used the virus and genetic material to develop a laboratory test to detect antibodies for contact tracing.
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SOME COUNTRIES NEED MORE HELP
Surveillance systems for the flu and other viruses are in place, with local health teams ready to test and report results to the CDC. “Surveillance for the novel coronavirus will take advantage of all of these existing methods and platforms,” reports Nicole Wetsman for Verge.
She explained that CDC expects local health labs to test any samples from patients showing symptoms that screen negative for influenza. Labs can also test combined samples to speed the process of pinpointing coronavirus locations.
The WHO has expressed concern about the coronavirus in Africa, with Egypt, Algeria and Nigeria each reporting one case. “The threats posed by COVID-19 has cast a spotlight on the shortcomings in health systems in the African Region,” said Matshidiso Moeti, WHO Regional Director for Africa, in a statement. Africa’s investments in preparation for the flu and Ebola, including laboratories, support the coronavirus response.
For this reason, the WHO has also encouraged rapid technology transfer for early diagnosis to help vulnerable populations since 2011.
“High-quality tests for infectious diseases are readily available in most developed countries; however, the situation is very different in developing countries, where the cost of imported IVD technology is frequently too high for the public sector,” notes a WHO report.
“The transfer of health-related technologies has been credited with the potential to build health security, increase reliability of supply, decrease reliance on imports, lead to lower prices, and encourage development and production that is more suitable for local health needs.”
Another challenge in developing diagnostic products: WHO warns tests can have short lifespans, as diseases subside or new products arrive to market.
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Susan Froetschel is editor of YaleGlobal Online. This commentary first appeared on YaleGlobal Online.